NCT Number: NCT05254223
The current study pretends to clarify, whether or not a healthy anti inflammatory diet improves different health-related outcomes in participants with rheumatoid arthritis.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
The current study pretends to clarify, whether or not a healthy anti-inflammatory diet improves different health-related outcomes: clinical, analytical, anthropometric and psychological outcomes in participants with rheumatoid arthritis. Due to the intervention has been based in a dietary advise, one of the goals of this study is also to evaluate the role of dietary advice in changing effectively the dietary patterns of the patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Any additional pathology or situation that could be considered, according to clinical criteria, of risk for the patient or for the study. for example:
The intervention group is recommended to follow a diet, inspired in mediterranean diet, rich in anti-inflammatory foods. They are provided with a table with the recommended foods as well as the frequency of daily/weekly/biweekly consumption.
The control group is recommended to follow their usual diet. Only in the case of detecting a serious nutritional problem the participant is recommended to correct it with the appropriate advice of the nutritionist.
Time frame: Day 0, month 4, month 8 and month12.
Disease activity is determined by Simplified Disease Activity Index (SDAI)
Time frame: Day 0, month 4, month 8 and month12.
Disease activity is determined by DAS28 score_ c reactive protein (DAS28-CRP)
Time frame: Day 0, month 4, month 8 and month12.
Disease activity is determined by DAS28 score_ erythrocyte sedimentation rate (DAS28-ESR)
Time frame: Day 0, month 4, month 8 and month12.
Disease activity is determined by Clinical Disease Activity Index (CDAI)
Time frame: Day 0, month 4, month 8 and month12.
Functional capacity is assessed by the Health Assessment Questionnaire (HAQ).
Time frame: Day 0, month 4, month 8 and month12.
Self-perceived health is evaluated by questionnaire EuroQol-5D-3L (EQ-5D)
Time frame: Month 12.
Global analysis of the dietary pattern during the intervention is evaluated by the food frequency questionaire (FFQ)
Time frame: Day 0, month 4, month 8 and month12.
Detailled analysis of diet is carried out by 24 hour dietary recall 3 days/week. Diet will be analyzed by HD-ENRICA diet analisys software (v17). Data analyzed will be: Energy (Kcal), Proteins (g), Carbohydrates (g), Fats (g), Fibre (g), vitamins (mg), minerals (mg), water (ml).
Time frame: Day 0, month 4, month 8 and month12.
Changes in MEDAS are carried out by MEDAS. 0 points means no adherence, 14 points means maximal adherence.
Time frame: Day 0, month 4, month 8 and month12.
Dietary inflammatory index are calculated with the information provides by 24 hour dietary recall 3 days/week.
Time frame: Every week from day 0 and during 12 months.
Participants report weekly self perception about pain, answering to a visual analogical scale where 0 means no pain and 10 is the maximum pain imaginable.
Time frame: Every week from day 0 and during 12 months.
Participants report weekly self perception about stiffness answering to a scale where 0 means no stiffness and 10 is the maximum stiffness imaginable.
Time frame: Every week from day 0 and during 12 months.
Participants report weekly self perception about inflammation answering to a scale where 0 means no stiffness and 10 is the maximum stiffness imaginable.
Time frame: Day 0, month 4, month 8 and month12.
Lipidomics profiling will be determined by plasma gas chromatography mass spectrometry (GC/MS). Lipidomics profiling in serum samples will be correlated with lipid intake.
Time frame: Day 0, month 4, month 8 and month12.
IL-1B, IL-4, IL-6, IL-10, IL-17, TNF-a, MCP1 will be analyzed by multiplex assay. Results will be correlated with Disease activity Indexes/scores.
Time frame: Day 0, month 4, month 8 and month12.
Participant's height (m) and weight (Kg) will be measured and body mass index (BMI) will be calculated.
Time frame: Day 0, month 4, month 8 and month12.
Body fat percentage (BFP) analyzed by bioelectrical impedance analysis (BIA).
Time frame: Day 0, month 4, month 8 and month12.
Body fat percentage (BFP) analyzed by anthropometric analysis acording to ISAK procedures (international standards for anthropometric assessment ) and using Siri formula where Fat %= [(4,95/density) - 4,5] * 100
Jose manuel Lou Bonafonte
Other
Effect of Long Term "Anti-inflammatory-diet" Advice in Patients With Rheumatoid Arthritis.
Acronym: AIDE-RAP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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